Alaway by Bausch & Lomb Incorporated Drug Facts

Alaway by

Drug Labeling and Warnings

Alaway by is a Otc medication manufactured, distributed, or labeled by Bausch & Lomb Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALAWAY- ketotifen fumarate 
Bausch & Lomb Incorporated

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Drug Facts

Active ingredient

Ketotifen 0.025%
(equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Uses

For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Warnings

For external use only

Do not use

• if you are sensitive to any ingredient in this product
• if solution changes color or becomes cloudy
• to treat contact lens related irritation

When using this product

• remove contact lenses before use
• wait at least 10 minutes before re-inserting contact lenses after use
• do not touch tip of container to any surface to avoid contamination
• replace cap after each use

Stop use and ask doctor if you experience any of the following:

• eye pain
• changes in vision
• redness of the eyes
• itching that worsens or lasts more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 3 years and older: put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day.

Children under 3 years of age: consult a doctor

Other Information

Store at 4-25°C (39-77°F)

Inactive ingredients

benzalkonium chloride, 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection

Questions or Comments?

Toll Free Product Information Call: 1-800-553-5340

Package/Label Principal Display Panel

NDC: 24208-901-99

BONUS 1ML TRAVEL SIZE

BAUSCH + LOMB

Alaway®

ketotifen fumarate ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS

UP TO

12

HOURS

EYE ITCH RELIEF

WORKS IN MINUTES!

▪ Original Prescription Strength

▪ For ages 3 years and older

[image – 1 mL Bottle]

[image – 10 mL Bottle]

STERILE 0.34 FL OZ (10 mL)+

0.03 FL OZ (1 mL)

ALAWAY 
ketotifen fumarate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24208-901

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24208-901-99	1 in 1 CARTON; Type 0: Not a Combination Product	12/01/2006

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, DROPPER	1 mL
Part 2	0 BOTTLE, DROPPER	1 mL

Part 1 of 2

ALAWAY 
ketotifen fumarate solution

Product Information
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G)	KETOTIFEN	0.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021996	12/01/2006

Part 2 of 2

ALAWAY 
ketotifen fumarate solution

Product Information
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G)	KETOTIFEN	0.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021996	12/01/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021996	12/01/2006	09/30/2015

Labeler - Bausch & Lomb Incorporated (196603781)

Establishment
Name	Address	ID/FEI	Business Operations
Bausch & Lomb Incorporated		079587625	MANUFACTURE(24208-901)

Revised: 12/2018

Document Id: 042fcd9c-36fa-423e-adf5-1001e5bccb37

34390-5

Set id: e99c2689-2408-4ab5-b8ff-406d8ed650e4

Version: 6

Effective Time: 20181203